You are here

A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

Last updated on August 9, 2018

FOR MORE INFORMATION
Study Location
P-one Clinic, Keikokai Medical Corporation
Hachioji-shi, Tokyo, 192-0071 Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Healthy
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
20-55 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Healthy female subjects (of childbearing or nonchildbearing potential) and/or male
subjects

- Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg and kg.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

?Evidence or history of clinically significant hematological, renal, endocrine, pulmonary,
gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease
(history of penicillin hypersensitivity and/or a history of sensitivity to allergens).

NCT03612557
Pfizer
Not yet recruiting
A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your zip code, city, or country to find studies near you.

Similar Trials

Healthy Volunteers
NCT03184168
Males
18+
Years
Madison, Wisconsin
Healthy Volunteers
NCT03593707
All Genders
18+
Years
Brussels,
Healthy
NCT03599063
All Genders
18+
Years
New Haven, Connecticut
A Study of Benzathine Benzylpenicillin Intramuscular Injection in Japanese Healthy Subjects
A Phase 1, Open-label Study To Investigate The Pharmacokinetics And Safety Of A Single Intramuscular Injection Of Benzathine Benzylpenicillin In Japanese Healthy Subjects
This will be an open label study to investigate the pharmacokinetics (PK) and safety of a single intramuscular injection of penicillin G benzathine in Japanese healthy subjects.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Healthy
Drug: penicillin G benzathine
2.4 million units (IM) of benzathine benzylpenicillin
Other Names:
  • penicillin G
  • benzathine benzylpenicillin
Experimental: active treatment arm
penicillin G benzathine treatment
Intervention: Drug: penicillin G benzathine
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
8
Same as current
October 28, 2018
October 28, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy female subjects (of childbearing or nonchildbearing potential) and/or male subjects
  • Body mass index (BMI) of 17.5 to 30.5 kg/m2; and a total body weight >50 kg and <100 kg.

Exclusion Criteria:

?Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (history of penicillin hypersensitivity and/or a history of sensitivity to allergens).

Sexes Eligible for Study: All
20 Years to 55 Years   (Adult)
Yes

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Japan
 
 
NCT03612557
B8441001
No
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Plan to Share IPD: No
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
July 2018

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]



Call Now